Expert Details
Veterinary Drugs, Veterinary Pharmaceuticals, Animal Drugs, Animal Pharmaceuticals
ID: 721920
Virginia, USA
Since 1992 he has worked as a consultant to the pharmaceutical industry for human and veterinary products. He is knowledgeable in the development of SOPs for GMP operations (human, veterinary and animal products), stability and method validation protocols. He has conducted GMP audits of bulk pharmaceutical chemicals (APIs) and dosage form manufacturing sites and operations, both foreign and domestic. He has also conducted GLP audits. Now he focuses on providing advice and assistance in the areas of human drugs and devices, and veterinary products. Particular focus is given to areas of GMPs, audits and regulatory affairs.
As a Staff Scientist at the Office of New Animal Drug Evaluation Center for Veterinary Medicine, he helped to develop international and FDA-industry Guidelines, he coordinated the Office-FDA Field/Foreign Inspections of Veterinary Manufacturing sites, and the CVM-Field Bio-Monitoring Research Activities. He also provided guidance in the review of Animal Drug Applications.
From 1975 to 1990, he was the Manager of the Manufacturing and Quality Control Unit in the Division of Chemistry in the Office of the Director, Office of New Animal Drug Evaluation, Center for Veterinary Medicine. There, he managed the reviews of manufacturing sections of New Animal Drug Applications, provided Quality Control to assure consistency of review, met with industry representatives to discuss applicable sections of NADA submissions, developed of guideline (stability and manufacturing) and conduct of training, and was Co-Editor of the Animal Drug Analytical
manual.
As an Analytical Chemist in the FDA Cincinnati District Office, he conducted analyses of human (pharmaceutical) and veterinary (pharmaceutical and medicated feeds) drugs, foods for food additives, pesticides in foods, drug residues, controlled and narcotic drugs, hazardous substances; and conducted research into the development of methods for laboratory use.
Education
| Year | Degree | Subject | Institution |
|---|---|---|---|
| Year: | Degree: BS | Subject: Chemistry | Institution: Wheeling Jesuit University |
| Year: | Degree: | Subject: Graduate Study-Advanced Chemistry | Institution: Cincinnati University |
| Year: | Degree: | Subject: Advanced Analytical Chemistry | Institution: Georgetown University |
| Year: | Degree: | Subject: Food and Drug Law | Institution: George Washington University |
Work History
| Years | Employer | Title | Department |
|---|---|---|---|
| Years: 1997 to Present | Employer: Undisclosed | Title: Senior Consultant | Department: |
Responsibilities:Responsibilities include providing advice and assistance in the areas of human drugs and devices, and veterinary products. Particular focus is given to areas of GMPs, audits and regulatory affairs. |
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| Years | Employer | Title | Department |
| Years: 1996 to 1997 | Employer: Independent Conultant | Title: Consultant to the Pharmaceutical Industry | Department: |
Responsibilities:Responsibilities included providing advice and assistance in the areas of regulatory affairs, cGMP requirements, development of SOPs and validation protocols. |
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| Years | Employer | Title | Department |
| Years: 1992 to 1996 | Employer: PennField Oil Co., Omaha, Nebraska | Title: Vice President for Government and Regulatory Affairs | Department: |
Responsibilities:Responsibilities included overseeing that operations at POC complied with FDA, EPA, and OSHA regulations; developing of SOPS and protocols; conducting visits of Foreign manufacturers (APIs) of POC products; conducting mock inspections of POC site and New Drug Substance manufacturing sites. |
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| Years | Employer | Title | Department |
| Years: 1990 to 1992 | Employer: FDA | Title: Staff Scientist, Manufacturing and Quality Control Generic Animal Drug and Quality Control Staff | Department: Office of New Animal Drug Evaluation Center for Veterinary Medicine |
Responsibilities:Available upon request. |
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| Years | Employer | Title | Department |
| Years: 1975 to 1990 | Employer: Center for Veterinary Medicine, FDA | Title: Manager (Branch Chief, Supervisory Chemist and Chief Chemist) | Department: Division of Chemistry in the Office of the Director, Office of New Animal Drug Evaluation |
Responsibilities:Available upon request. |
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| Years | Employer | Title | Department |
| Years: 1967 to 1975 | Employer: FDA | Title: Scientific Coordinator–Chemist in the Field Sciences Branch | Department: Division of Field Operations in the office of the Executive Director for Regional Operations |
Responsibilities:Responsibilities included coordinating/managing analytical activities of FDA field Scientists relative to the conduct of responsible FDA field and headquarters program activities: coordinating analytical methodology and quality control functions; coordinate test of new human and veterinary drugs and food additives as presented in formal applications; conducting training exercises and developing methodology as needed; editing of Food Additive and Animal Drug Analytical manuals. |
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| Years | Employer | Title | Department |
| Years: 1962 to 1967 | Employer: FDA | Title: Analytical Chemist | Department: Cincinnati District Office |
Responsibilities:Available upon request. |
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Government Experience
| Years | Agency | Role | Description |
|---|---|---|---|
| Years: 1962 to 1992 | Agency: FDA | Role: | Description: |
Career Accomplishments
| Associations / Societies |
|---|
| He is a member of the American Chemical Society, the Parenteral Drug Association, and the Regulatory Affairs Professional Society. |
| Publications and Patents Summary |
|---|
| He is the author of several publications. |
Fields of Expertise
Food and Drug Administration, Chemistry, Manufacturing and Controls, Good Manufacturing Practice, standard operating procedure, veterinary medicine, Food and Drug Administration regulation, Food and Drug Administration compliance, Food and Drug Administration National Drug Code, animal drug testing, veterinary pharmacology, food additive, pesticide, pesticide toxicity, carp farming, animal feed industry, drug evaluation, drug regulation